PMID- 25122422
OWN - NLM
STAT- MEDLINE
DCOM- 20150512
LR  - 20220316
IS  - 1556-1380 (Electronic)
IS  - 1556-0864 (Linking)
VI  - 9
IP  - 9
DP  - 2014 Sep
TI  - Canadian anaplastic lymphoma kinase study: a model for multicenter 
      standardization and optimization of ALK testing in lung cancer.
PG  - 1255-63
LID - 10.1097/JTO.0000000000000239 [doi]
AB  - INTRODUCTION: Fluorescence in situ hybridization (FISH) is currently the standard 
      for diagnosing anaplastic lymphoma kinase (ALK)-rearranged (ALK+) lung cancers 
      for ALK inhibitor therapies. ALK immunohistochemistry (IHC) may serve as a 
      screening and alternative diagnostic method. The Canadian ALK (CALK) study was 
      initiated to implement a multicenter optimization and standardization of 
      laboratory developed ALK IHC and FISH tests across 14 hospitals. METHODS: 
      Twenty-eight lung adenocarcinomas with known ALK status were used as blinded 
      study samples. Thirteen laboratories performed IHC using locally developed 
      staining protocols for 5A4, ALK1, or D5F3 antibodies; results were assessed by 
      H-score. Twelve centers conducted FISH using protocols based on Vysis' ALK 
      break-apart FISH kit. Initial IHC results were used to optimize local IHC 
      protocols, followed by a repeat IHC study to assess the results of 
      standardization. Three laboratories conducted a prospective parallel IHC and FISH 
      analysis on 411 consecutive clinical samples using post-validation optimized 
      assays. RESULTS: Among study samples, FISH demonstrated 22 consensus ALK+ and six 
      ALK wild type tumors. Preoptimization IHC scores from 12 centers with 5A4 and the 
      percent abnormal cells by FISH from 12 centers showed intraclass correlation 
      coefficients of 0.83 and 0.68, respectively. IHC optimization improved the 
      intraclass correlation coefficients to 0.94. Factors affecting FISH scoring and 
      outliers were identified. Post-optimization concurrent IHC/FISH testing in 373 
      informative cases revealed 100% sensitivity and specificity for IHC versus FISH. 
      CONCLUSIONS: Multicenter standardization study may accelerate the implementation 
      of ALK testing protocols across a country/region. Our data support the use of an 
      appropriately validated IHC assay to screen for ALK+ lung cancers.
FAU - Cutz, Jean-Claude
AU  - Cutz JC
AD  - *Department of Pathology and Molecular Medicine, McMaster University Health 
      Sciences Centre and McMaster University, Hamilton, Ontario; daggerDepartment of 
      Pathology, University Health Network, Princess Margaret Cancer Centre and 
      University of Toronto, Toronto, Ontario; double daggerDepartment of Pathology, Jewish General 
      Hospital and Lady David Institute, McGill University, Montreal, Quebec;  section signCross 
      Cancer Institute and Department of Laboratory Medicine & Pathology, University of 
      Alberta, Edmonton, Alberta;  ||Department of Molecular Pathology, University of 
      Alberta Hospital, Edmonton, Alberta;  paragraph signDepartment of Pathology, Queen Elizabeth II 
      Health Sciences Centre and Dalhousie University, Halifax, Nova Scotia; 
      #Department of Pathology, Aichi Cancer Center Hospital, Nagoya, Japan; 
      **Department of Pathology, British Columbia Cancer Agency and University of 
      British Columbia, Vancouver, British Columbia; daggerdaggerDepartment of Pathology, McGill 
      University Health Centre, Montreal, Quebec; double daggerdouble daggerDepartment of Human Genetics, 
      McGill University, Montreal, Quebec;  section sign section signDepartment of Pathology, Health Sciences 
      North, Sudbury, Ontario;  || ||Department of Pathology and Laboratory Medicine, 
      University of Calgary, Calgary, Alberta;  paragraph sign paragraph signDepartment of Pathology, The Ottawa 
      Hospital and University of Ottawa, Ottawa, Ontario; ##Centre hospitalier de 
      l'Universite de Montreal, Montreal, Quebec; ***Department of Pathology, London 
      Health Sciences Centre, London, Ontario; daggerdaggerdaggerDepartment of Molecular Genetics, 
      University of Toronto, Toronto, Ontario; double daggerdouble daggerdouble daggerDepartment of Pathology, Harvard 
      Medical School, Massachusetts General Hospital, Boston, MA;  section sign section sign section signPfizer Oncology 
      Canada, Kirkland, Quebec; and  || || ||Institut Universitaire de Cardiologie et de 
      Pneumologie de Quebec (Hopital Laval), Universite Laval, Quebec, Quebec.
FAU - Craddock, Kenneth J
AU  - Craddock KJ
FAU - Torlakovic, Emina
AU  - Torlakovic E
FAU - Brandao, Guilherme
AU  - Brandao G
FAU - Carter, Ronald F
AU  - Carter RF
FAU - Bigras, Gilbert
AU  - Bigras G
FAU - Deschenes, Jean
AU  - Deschenes J
FAU - Izevbaye, Iyare
AU  - Izevbaye I
FAU - Xu, Zhaolin
AU  - Xu Z
FAU - Greer, Wenda
AU  - Greer W
FAU - Yatabe, Yasushi
AU  - Yatabe Y
FAU - Ionescu, Diana
AU  - Ionescu D
FAU - Karsan, Aly
AU  - Karsan A
FAU - Jung, Sungmi
AU  - Jung S
FAU - Fraser, Richard S
AU  - Fraser RS
FAU - Blumenkrantz, Miriam
AU  - Blumenkrantz M
FAU - Lavoie, Josee
AU  - Lavoie J
FAU - Fortin, Flechere
AU  - Fortin F
FAU - Bojarski, Anna
AU  - Bojarski A
FAU - Cote, Gilbert B
AU  - Cote GB
FAU - van den Berghe, Janette A
AU  - van den Berghe JA
FAU - Rashid-Kolvear, Fariborz
AU  - Rashid-Kolvear F
FAU - Trotter, Martin
AU  - Trotter M
FAU - Sekhon, Harmanjatinder S
AU  - Sekhon HS
FAU - Albadine, Roula
AU  - Albadine R
FAU - Tran-Thanh, Danh
AU  - Tran-Thanh D
FAU - Gorska, Isabelle
AU  - Gorska I
FAU - Knoll, Joan H M
AU  - Knoll JH
FAU - Xu, Jie
AU  - Xu J
FAU - Blencowe, Ben
AU  - Blencowe B
FAU - Iafrate, A John
AU  - Iafrate AJ
FAU - Hwang, David M
AU  - Hwang DM
FAU - Pintilie, Melania
AU  - Pintilie M
FAU - Gaspo, Rania
AU  - Gaspo R
FAU - Couture, Christian
AU  - Couture C
FAU - Tsao, Ming-Sound
AU  - Tsao MS
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Thorac Oncol
JT  - Journal of thoracic oncology : official publication of the International 
      Association for the Study of Lung Cancer
JID - 101274235
RN  - 0 (DNA, Neoplasm)
RN  - EC 2.7.10.1 (ALK protein, human)
RN  - EC 2.7.10.1 (Anaplastic Lymphoma Kinase)
RN  - EC 2.7.10.1 (Receptor Protein-Tyrosine Kinases)
SB  - IM
CIN - J Thorac Oncol. 2014 Sep;9(9):1237-9. PMID: 25122418
MH  - Adenocarcinoma/diagnosis/*enzymology/genetics
MH  - Adenocarcinoma of Lung
MH  - Anaplastic Lymphoma Kinase
MH  - Canada
MH  - DNA, Neoplasm/genetics
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence/methods
MH  - Lung Neoplasms/diagnosis/*enzymology/genetics
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Receptor Protein-Tyrosine Kinases/genetics/*metabolism
MH  - Reproducibility of Results
MH  - Reverse Transcriptase Polymerase Chain Reaction
EDAT- 2014/08/15 06:00
MHDA- 2015/05/13 06:00
CRDT- 2014/08/15 06:00
PHST- 2014/08/15 06:00 [entrez]
PHST- 2014/08/15 06:00 [pubmed]
PHST- 2015/05/13 06:00 [medline]
AID - S1556-0864(15)30669-9 [pii]
AID - 10.1097/JTO.0000000000000239 [doi]
PST - ppublish
SO  - J Thorac Oncol. 2014 Sep;9(9):1255-63. doi: 10.1097/JTO.0000000000000239.